Viridian Reports Long-Term Data for Veligrotug in TED

Viridian Therapeutics has announced encouraging long-term durability data from its phase 3 THRIVE clinical trial evaluating veligrotug for the treatment of active thyroid eye disease (TED). The new findings reinforce veligrotug’s sustained efficacy, safety, and potential to become a leading therapeutic option for TED.

About Veligrotug: A Next-Generation IGF-1R Inhibitor

Veligrotug is an intravenously (IV) administered anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, designed to treat TED. Viridian highlights its differentiated dosing regimen, which includes shorter infusion times and fewer total infusions compared to currently approved IGF-1R inhibitors. This may significantly enhance patient convenience and adherence.

THRIVE Phase 3 Trial: Design and Long-Term Results

The THRIVE phase 3 study assessed the efficacy and safety of veligrotug in patients with active TED. Participants received either veligrotug or placebo via 5 infusions, each spaced 3 weeks apart. The trial’s primary analysis occurred at week 15, with extended follow-up continuing through week 52.

Week 52 Durability Findings:

• 70% of veligrotug-treated patients (21/30) who were proptosis responders at week 15 maintained their response at week 52.

• Maintenance of response was defined as maintaining a ≥2 mm reduction in proptosis from baseline, with no worsening in the fellow eye (defined as ≥2 mm increase).

• The safety profile remained stable, with no new safety signals observed during the extended follow-up. Most adverse events reported at week 15 resolved by week 52.

Expert Commentary

Steve Mahoney, President and CEO of Viridian Therapeutics, stated:

“We view the strength of today’s durability and safety resolution data as reinforcing veli’s strong and consistently robust clinical profile. We believe that the totality of veligrotug’s clinical data continues to demonstrate its potential to be the treatment-of-choice for patients living with TED. These data, together with a streamlined dosing regimen of five infusions, position veli to become a market leading TED therapeutic, if approved.”

Veligrotug's Clinical Performance and Regulatory Status

As previously reported, the THRIVE trial met both its primary and all secondary endpoints at the 15-week mark. In parallel, the THRIVE-2 trial also achieved all primary and secondary endpoints following 5 veligrotug infusions at week 15.

In recognition of its potential, veligrotug has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). This designation is reserved for therapies addressing serious or life-threatening conditions with evidence of substantial improvement over existing treatments.

Regulatory Plans and Pipeline Outlook

Viridian plans to submit a Biologics License Application (BLA) for the veligrotug for the treatment of TED in the second half of 2025, with a potential market launch in 2026, pending regulatory approval.